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Quality Assurance

Chemists in the Field

Overview

Quality management activities are those that ensure that a company’s products are exactly what they are supposed to be, that is, they meet all their specifications. Quality assurance (QA) and quality control (QC) are two of the main activities that are required to ensure a quality product. QA and QC are closely related, but they are different concepts. QA is a set of activities that ensures that development and/or maintenance processes are adequate in order for a system to meet its objectives, whereas QC is a set of activities designed to evaluate the developed products. Another way to look at it would be to think of QA as preventing and detecting quality problems and QC as detecting errors in the product.

Chemists who work in quality assurance enjoy finding ways to reduce the possibility of error in manufacturing methods by using a big-picture view of product quality.

Typical Quality Assurance Duties

Develop and validate methods for analyzing and producing products to ensure they meet specifications and document those methods in standard operating procedures (SOPs) and production records

Audit quality control, production and sales functions, and other records to ensure compliance with SOPs

Assist quality control staff with troubleshooting and resolving unusual problems

Participate in audits by customers and regulatory agencies and respond to customer complaints

Education

Quality assurance auditor positions generally require a bachelor’s degree in a related field. For example, an auditor in a medical device company might have a degree in a life science, nursing, or pharmacy. Career advancement for quality assurance personnel with a bachelor’s degree is more likely than in other types of work, but an advanced degree is still an advantage—especially if supervisory work is desired.

Workspace

Quality assurance work is most often conducted in an office and involves a lot of documentation.

Technical Skills

Prioritization

Attention to Detail

Communication

Ability to prioritize multiple projects and deadlines

Good judgment and decision-making skills

Meticulous attention to detail, excellent organizational skills, and investigative abilities for when a problem arises

Technical writing skills are essential

Background Knowledge

Interpersonal

Familiarity with guidelines such as good laboratory practices, good manufacturing processes, and good clinical practices (collectively known as GXPs), as well as ISO (International Standards Organization) 9000, is helpful

Ability to prioritize multiple projects and deadlines

Unwavering integrity

Career Path

As long as there are regulations, there will be a need for people to make sure they are being followed. Over time, quality assurance professionals generally move up to larger projects with more responsibilities and rewards, which may include learning the regulatory landscape in other countries. Eventually, they may move away from day-to-day operations and into more strategic planning positions, where they are looking at the bigger picture of quality.

Other Resources

Future Employment Trends

As long as there are regulations, there will be a need for quality assurance scientists to develop and institute procedures and processes that ensure all requirements for creating quality products will be fulfilled.

Is This Career a Good Fit for You?

If you like to work independently and can focus on details to ensure that procedures (standards) are followed exactly as written, this may be the career for you. You must have a strong sense of ethics as well as the ability to stand your ground without antagonizing the team. Ideally, you will be seen as a coach and educator, rather than an enforcer. Since regulations are continually updated, lifelong learning is essential.

Opportunities

As long as there are regulations, there will be a need for quality assurance scientists to develop and institute procedures and processes that ensure all requirements for creating quality products will be fulfilled.

Education

Many quality assurance scientists have a bachelor’s degree in chemistry, though an advanced degree can be useful in certain industries. Industrial laboratory experience is highly valuable.

Salaries

Current salary data for this sub-specialty is not currently available.